Indonesia: Influenza Scientists, WHO Face Off In Virus Row
2008-10-03
JAKARTA, INDONESIA: It's a David and Goliath battle that could affect the world's ability to monitor diseases and develop lifesaving vaccines. The key issue: Should Indonesia and other developing nations have a say over crucial genetic data about their own deadly viruses?
An international network of top influenza scientists says yes, arguing that is the best way to speed development and research, but they are running into resistance from within the World Health Organization, which opposes letting countries keep intellectual property rights to virus samples they provide for research.
The intensifying standoff was triggered in part by revelations that the WHO, for years looked upon as the protector of the poor, had been keeping coveted information about bird flu and other viruses in a private database in Los Alamos, New Mexico, and making it available to just 15 laboratories.
Some foreign governments called for a boycott of the global body's 55-year-old virus-sharing system, which had obliged them to freely hand over samples and data.
The problem with that system, they say, is that developing countries give up intellectual property rights to their virus samples when they provide them to the WHO. The virus samples are then used by private pharmaceutical companies to make vaccines that are awarded patents _ and sold at a profit at prices many poor nations can't afford.
Acknowledging a need for change, the WHO agreed to work with developing nations to make sure they had better access to lifesaving medicine, an intensely bureaucratic process that is about to enter its second year with no clear end in site.
In the meantime, leading influenza scientists and health experts came up with their own solution to alleviate the basic concerns of transparency for developing nations, one that appears to be making some at the WHO nervous.
The scientists' nonprofit organization, which goes by the name of GISAID, launched a publicly accessible online database that _ for the first time ever _ offers basic intellectual property rights to those who submit genetic information.
That has encouraged many countries including Indonesia, China, Russia
and others to again start sharing information about their viruses, turning GISAID into the world's largest and most comprehensive influenza database in just four months
"I'm in favor of what works. If nothing is working, we have to come up with something new," said Bruce Lehman, who served as Commissioner of Patents and Trademarks under U.S. President Bill Clinton. "And if you have a mechanism that is going to encourage the
dissemination of scientific data, of research, well, then that is going to be positive in terms of coming up with new treatments for disease."
However, the WHO appears to be going to extreme lengths to stand in GISAID's way, including withholding funding that has been pledged for the database.
The World Health Organization, meanwhile, is seeking US$10 million for its own database and virus tracking system, even though its own scientists are already using GISAID's free-of-charge site almost exclusively, including for last month's virus strain selection for the annual flu shot, said Masato Tashiro, director of WHO's collaborating center at Japan's National Institute of Infectious Diseases.
Because many scientists played a key role in helping design the system to meet their needs, they are befuddled at the WHO Secretariat's refusal to embrace them. David Heymann, the global body's top flu official, said the reason was simple. For the first time in decades, developing countries are looking at the global body with mistrust, and officials cannot afford to be partial to any group, he said, adding this was a direct order from WHO
Director-General Margaret Chan.
Heymann supports keeping viruses in the public domain _ something that effectively strips countries of ownership rights _ and, until recently, other top officials in Geneva maintained it was important some genetic data remained behind closed doors.
In the most recent dispute over GISAID's free database, the WHO has refused to hand over US$450,000 provided by the U.S. Centers of Disease Control for the database's development well over a year ago. That is a lot of money for the feisty group of influenza scientists, given that their director, Peter Bogner, a former television broadcaster who rallied to their cause two years ago, has largely financed the initiative on his own.
"We are working with WHO to get these funds mobilized for their intended purposes," said Bill Hall, spokesman for the U.S. Department of Health and Human Services, also frustrated after receiving conflicting reasons for the delay.
The WHO's Heymann said CDC money had been earmarked for a specific project _ a database _ but not a particular organization. "We have to go through a competitive bidding process," he told AP _ a process in which GISAID would be ineligible to compete because it is a nonprofit organization.
Developing nations, which have a key stake in the project, meanwhile alleged that a WHO-commissioned report comparing five databanks, from GenBank to Los Alamos, carried out by the global body's four collaborating centers was deliberately kept secret.
Scientists ranked GISAID superior on almost all levels, from the amount and type of information included to functionality, but several member states said, when requesting an update, they were told no assessment had been carried out.
Indonesian Health Minister Siti Fadilah Supari said Friday (3 Oct) if the goal was to force members states to use an expensive and substandard database and tracking system created by WHO, it wouldn't work. "It would certainly add the lingering mistrust many feel toward WHO," she said. (By ROBIN McDOWELL/ AP
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Scientists launch effort to share avian flu data
Robert Roos News Editor
Aug 25, 2006 (CIDRAP News) ? Leading medical researchers yesterday announced the formation of a consortium to unlock genetic and other data on avian influenza in the hope of improving the understanding of how viruses such as H5N1 spread and evolve. A letter published online yesterday by Nature,signed by 70 scientists and health officials, announced the launch of the Global Initiative on Sharing Avian Influenza Data (GISAID). Authors of the letter include Dr. Nancy Cox, head of the Influenza Division at the US Centers for Disease Control and Prevention (CDC), and Ilaria Capua, an Italian veterinary virologist who is a leading advocate of greater sharing of H5N1 genetic data.
"The Initiative is coming together to work around restrictions which have previously prevented influenza information sharing, with the hope that more shared information will help researchers understand how viruses spread, evolve, and potentially become pandemic," states a news release on the GISAID Web site.
The consortium "is open to all scientists, provided they agree to share their own data, credit the use of others' data, analyze findings jointly, and publish results collaboratively," the release says. The Nature letter says that data will be published in three public databases "as soon as possible after analysis and validation, with a maximum delay of six months."
Details are still being worked out, but the participants have agreed to deposit genetic data into secure sections?not yet set up?of existing public databases, according to a Nature news article published yesterday. The data will initially be accessible only to the consortium researchers, but will be opened to public access within 6 months.
The consortium said it will use the three databases participating in the International Nucleotide Sequence Database Collaboration: EBML in the United Kingdom, DDBJ in Japan, and GenBank in the United States.
Yesterday's announcement is the second major development this week affecting the availability of genetic data on flu viruses. Two days ago the CDC said it was depositing the blueprints for 650 human flu virus genes in GenBank, a public database, and would release data on several hundred more flu viruses each year henceforth. The data are from viruses collected in the United States.
Scientists have complained in recent months about the withholding of genetic sequences of flu viruses, especially H5N1. The World Health Organization (WHO) obtains such data as its affiliated laboratories analyze viruses, but the WHO releases the data only with permission from the country of origin. Some countries battling H5N1 have refused to allow release of the information. Indonesia, an H5N1 hot spot, had long refused to authorize release of data on its viruses, but earlier this month the government changed its stance.
In a telephone interview, Cox said the goal of GISAID is to share clinical and epidemiologic information as well as genetic data on avian flu cases.
"The aim is that eventually the data will be linked together so there will be not only the sequence data but also the clinical and epidemiologic data," she told CIDRAP News. "The sequences become much more meaningful with other data linked to them."
Clinical information would include such things as the patient's age, whether he or she survived the illness, how long the illness lasted, and what part of the body a specimen was taken from, she said.
"All of this information is very useful when you're trying to understand the evolution of the virus," Cox said, adding that data would be stripped of personal identifiers.
Public genetic databases aren't necessarily set up to accommodate additional information beyond the bare sequence data, and some work will be required to remedy that, Cox said. For example, a database should have fields for such information as whether the virus came directly from a clinical specimen or from an isolate obtained by amplifying the original specimen, she explained.
"All of these details are potentially very important because they can have an impact on the sequence itself," she said. GISAID will include experts in animal and human virology, epidemiology, bioinformatics, and intellectual property issues, according to the Nature letter.
A concern of developing countries battling the H5N1 virus is that they won't benefit from releasing data derived from samples they collect, because any resulting drugs or vaccines will be too expensive. Because of this, Cox said, "There really is going to be a lot of effort put into the intellectual property rights issue to assure proper acknowledgment of the origin of the sequences and recognize the scientists and the public health workers in the country of origin of the virus."
A group within the consortium will focus on intellectual property issues, Cox said. They will work to credit the scientists who are on the front lines in affected countries and also "to determine if there are ways the consortium could help facilitate benefits for those countries that are hardest hit by avian flu."
The equity issue has been discussed a lot, she added. "We don't have the solutions yet, but it's an area that needs to be tackled." Cox said scientists working for pharmaceutical companies could participate in the consortium. "Pharmaceutical manufacturers would be able to look at the data, and, for example, if they 're trying to design new antiviral drugs for H5N1 or other flu viruses, they'd be able to use the data to do that," she said.
The director of GISAID is Peter Bogner, chief executive of the Bogner Organization, Santa Monica, Calif. He is an author of the Natureletter, along with Cox; Capua, who chairs the scientific committee of the joint avian flu expert panel of the World Organization for Animal Health (OIE) and the United Nations Food and Agriculture Organization; and David J. Lipman, director of the US National Center for Biotechnology Information.
According to the Naturenews article, Capua started something of a rebellion against the hoarding of avian flu virus data last March, when she put her own H5N1 sequence data into GenBank instead of in the protected database used by WHO-linked labs, and challenged others to do the same.
Capua then collaborated with Bogner, who talked with many scientists and policymakers about the issue, according to the article. Subsequently, the OIE-FAO avian flu expert panel (OFFLU) endorsed the consortium idea.
The 70 signers of the Nature letter include researchers and health officials from countries around the world, including those hard-hit by H5N1 avian flu, such as Thailand, Indonesia, Vietnam, China, Cambodia, Egypt, and Turkey, as well as countries not yet affected.
Cox said the consortium is "really at a very formative stage right now. There's a lot of groundswell of support for it. There's a lot of enthusiasm, but it's just the beginning."
See also:
GISAID letter to Nature
GISAID news release
Nature news story
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